K-number	K210973
Device name	MammaPrint FFPE NGS Kit
Applicant	Agendia, Inc.
Product code	NYI
Device class	Class II
Decision date	Sep 8, 2022
Decision	Substantially Equivalent
Regulation	866.6040

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Source

View the full FDA submission: accessdata.fda.gov

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MammaPrint FFPE NGS Kit

Everything you need for a 510(k) submission. Nothing you don't.